Silverstone Interbody System Surgical Technique

Silverstone Interbody System Surgical Technique

TABLE OF CONTENTS Design Rationale Instructions for Use Surgical Technique 1. Disc Space Preparation 2. Distraction 3. Implant Selection 4. Implant Placement 5. Implant Removal

DESIGN RATIONALE 2 1 3 22 and 28mm Lengths Inserter supports less invasive procedures 22, 26, and 30mm Lengths Large axial graft window Tapered, self-distracting leading edge 6mm through 16mm Heights

INDICATIONS FOR USE The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ( DDD ) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System. Reference product insert (PI-002) for complete system indications for use, description, warnings and precautions

1. DISC SPACE PREPARATION PREPARE DISC SPACE AND ENDPLATES Assemble the appropriate Shaver-Distractor to the T-Handle Pull back the plunger and insert the shaft until the load line is flush with the plunger, then release Insert the Shaver-Distractor into the disc space with its flat surface parallel to the endplates Rotate the Shaver-Distractor in a clockwise direction to shave the endplates Note: Clockwise rotation will shave the endplates; counterclockwise rotation provide blunt distraction

2. DISTRACTION DISTRACT A starter size of 6mm is available for initial distraction, sizes increase sequentially by 1mm Assemble the appropriate size Shaver-Distractor to the T-Handle Pull back the plunger and insert the shaft until the load line is flush with the plunger, then release Insert the Shaver-Distractor into the disc space with its flat surface parallel to the endplates Rotate the Shaver-Distractor assembly in a counterclockwise direction to distract the disc space Incrementally introduce increasing heights Shaver-Distractors until the desired height is achieved

3. IMPLANT SELECTION TRIAL USAGE Select an appropriately sized Implant Trial in the desired footprint; starting size is 6mm and height increases sequentially by 1mm Assemble the appropriate size Trial to the T-Handle Pull back the plunger an insert the shaft until the load line is flush with the plunger, then release Insert the trial assembly into the disc space, impact the trial assembly if necessary Confirm the position and fit of the trial Implant length can be estimated using the etched lines of the trial Note: Straight and curved trials are available based on the implant being used REMOVE TRIAL A Slap Hammer is available to aid in removing the trial assembly from the disc space Attach the Slap Hammer to the distal end of the trial assembly Remove trial assembly from disc space

4. IMPLANT PLACEMENT ASSEMBLE IMPLANT TO INSERTER Select the appropriately sized implant with the desired footprint Utilize the Graft Block and Tamp to pack the Implant with autograft Engage the forks of the Inserter into the female treaded portion of the implant Insert the Implant into the disc space by manual manipulation or instrument impaction using the inserter handle REMOVE THE INSERTER Rotate the thumbwheel on the Inserter in a counterclockwise motion to release the implant from the Inserter Utilize the Tamp or Angled Impactor for additional implant manipulation

5. IMPLANT REMOVAL USING IMPLANT INSERTER Thread the Implant Inserter to the implant Attach the Slap Hammer to the end of the Implant Inserter Remove assembly from disc space USING IMPLANT REMOVER Using the hook of the Remover, engage a window on the side of the implant Thread the inner rod of the Remover into the female threaded portion of the implant Use the etch window of the Remover to help ensure the implant is fully engaged Attach the Slap Hammer to the end of the Remover Remove assembly from disc space

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